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Alejandra Roman Gonzalez

Alejandra Roman-Gonzalez is a support specialist in Baker McKenzie Mexico office.

On 16 November 2021 a new Coordination Agreement (CA) over Health Control, executed between the Federal Ministry of Health and the State of Baja California (“Baja”), was published on the Federation’s Official Gazette. This new CA has a particular impact over the medical devices industry operating in Baja, improving greatly the regulatory environment.

There is a clear increase of enforcement actions taken by health authorities, both at the Federal and State level, where authorities are verifying if both physician and dining rooms at manufacturing plants, from all industries, have been properly supported by the applicable Notices of Operation. At the same time, many local health authorities are unduly requesting companies to have a Notice of Operation for their manufacturing operations. Companies shall comply the former and be prepared to reject the latter in order to prevent disruptions of operations and future sanctions.